Dr. William Williams reports

BRIACELL RECEIVES FDA CLEARANCE TO INITIATE BRIA-PROS+™ CLINICAL STUDY IN PROSTATE CANCER

The United States Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for Briacell Therapeutics Corp.'s Bria-PROS+ and issued a study may proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.

• FDA clearance of investigational new drug (IND) application enables Briacell to initiate phase 1/2a clinical study of Bria-PROS+ in prostate cancer;
• Bria-PROS+ is Briacell's next-generation personalized immunotherapy for prostate cancer and incorporates additional immune activating components designed to enhance clinical efficacy;
• Bria-PROS+ program previously awarded $2-million grant from the U.S. National Cancer Institute.

"We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer," stated Dr. William V. Williams, Briacell's president and chief executive officer. "Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favourable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we work to develop new treatment options for patients with advanced prostate cancer."

In August, 2025, Briacell was awarded a $2-million non-dilutive grant from the U.S. National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.

As reported in Briacell's preclinical poster presentation, at the American Association of Cancer Research (AACR) annual meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naive (resting) T-cells, dendritic cells and natural killer (NK) cells. Briacell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with prostate cancer.

Briacell's Bria-PROS+ builds on the company's oncology platform with its Bria-IMT program, currently in its phase 3 pivotal trial for metastatic breast cancer, its Bria-OTS breast cancer clinical program, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and its Bria-BRES+ program, which recently received FDA clearance to initiate clinical evaluation of its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer. Bria-PROS+, Bria-OTS and Bria-BRES+ programs are personalized immunotherapies, based on HLA matching between patients and the respective immunotherapy cell lines.

About Briacell Therapeutics Corp.

Briacell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer.

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